Xanthosine Clinical Trials

Size	Price	Qty
10mg	USD 70
100mg	USD 327

Clinical Trials

A clinical trial sponsored by Fujifilm Pharmaceuticals U.S.A. Inc. evaluated therapeutic strategies involving this purine metabolic compound for hematologic indications. This completed Phase 1/2 study investigated dose escalation, safety, and efficacy in patients with advanced hematologic malignancies, specifically acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and myelodysplastic syndromes (MDS). The investigation aimed to characterize preliminary therapeutic responses and establish effective dosing regimens in these specific patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02193958	Completed	AML\|CMML\|MDS	Fujifilm Pharmaceuticals U.S.A. Inc.	2014-07	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Xanthosine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Xanthosine serves as a key nucleoside intermediate within the purine biosynthetic pathway, functioning in the enzymatic conversion of inosine monophosphate into guanosine monophosphate to maintain cellular nucleic acid precursor pools. By participating in guanine nucleotide turnover, its metabolic modulation directly regulates RNA and DNA synthesis, which subsequently impairs rapidly proliferating blast cells in hematologic conditions such as acute myeloid leukemia, chronic myelomonocytic leukemia, and myelodysplastic syndromes.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).